Vaccination with multiple clades of H5 influenza A virus

Patent metadata

Field	Value
Publication number	US-9669088-B2
Application number	US-74492008-A
Country	US
Kind code	B2
Filing date	Nov 25, 2008
Priority date	Nov 26, 2007
Publication date	Jun 6, 2017
Grant date	Jun 6, 2017

Abstract

H5N1 influenza viruses isolated from animals and humans since 2003 separate into distinct clades based on hemagglutinin amino acid sequences. According to the invention, multiple clades are used in influenza immunization. Thus there is a prime-boost immunization schedule where a subject receives a priming dose of a first clade of H5 influenza A virus and a boosting dose of a second clade of H5 influenza A virus. There is also an immunogenic composition comprising hemagglutinin antigens from more than one clade of H5 influenza A virus.

First claim

The invention claimed is:

1. A method for immunizing a patient, the method comprising a step of: administering to the patient an immunogenic composition comprising a hemagglutinin antigen from a second clade of H5 influenza A virus,
wherein the patient was previously immunized with an adjuvanted influenza vaccine comprising a hemagglutinin antigen from a first clade of H5 influenza A virus;
wherein the adjuvanted influenza vaccine comprises an oil-in-water emulsion;
and wherein the first and the second clades are different.

2. The method of claim 1 , wherein the immunogenic composition comprises 15 μg, 7.5 μg, or 3.75 μg hemagglutinin antigen from the second clade of H5 influenza A virus.

3. The method of claim 1 , wherein the patient was immunized with the adjuvanted influenza vaccine comprising the hemagglutinin antigen from the first clade of H5 influenza A virus at least 9 months, at least 12 months, at least 18 months, at least 24 months, at least 36 months, at least 48 months or at least 60 months previously.

4. The method of claim 1 , where the first clade is clade 1 and the second clade is clade 2.

5. The method of claim 1 , where the first clade is clade 2 and the second clade is clade 1.

6. The method of claim 1 , where the first clade is clade 1 and the second clade is not clade 2.

7. The method of claim 1 , where the first clade is clade 2 and the second clade is not clade 1.

8. The method of claim 1 , wherein the immunogenic composition and/or the adjuvanted influenza vaccine is a split vaccine.

9. The method of claim 1 , wherein the immunogenic composition and/or the adjuvanted influenza vaccine is a purified subunit vaccine.

10. The method of claim 1 , wherein the immunogenic composition and/or the adjuvanted influenza vaccine includes influenza A virus neuraminidase.

11. The method of claim 1 , wherein the immunogenic composition comprising the second clade antigen is adjuvanted with an oil-in-water emulsion-adjuvant.

12. A method for immunizing a patient, the method comprising steps of:
(i) administering to the patient a first influenza vaccine comprising a hemagglutinin antigen from a first clade of H5 influenza A virus and an oil-in-water emulsion; and
(ii) administering to the patient a second influenza vaccine comprising a hemagglutinin antigen from a second clade of H5 influenza A virus;
wherein the first and the second clades are different.

13. The method of claim 12 , wherein the influenza vaccine comprises 15 μg, 7.5 μg, or 3.75 μg hemagglutinin antigen from the second clade of H5 influenza A virus.

14. The method of claim 12 , wherein the influenza vaccine comprising the hemagglutinin antigen from the first clade of H5 influenza A virus is administered at least 9 months, at least 12 months, at least 18 months, at least 24 months, at least 36 months, at least 48 months or at least 60 months before administration of the influenza vaccine comprising the hemagglutinin antigen from the second clade of H5 influenza A virus.

15. The method of claim 12 , where the first clade is clade 1 and the second clade is clade 2.

16. The method of claim 12 , where the first clade is clade 2 and the second clade is clade 1.

17. The method of claim 12 , where the first clade is clade 1 and the second clade is not clade 2.

18. The method of claim 12 , where the first clade is clade 2 and the second clade is not clade 1.

19. The method of claim 12 , wherein the first and/or the second influenza vaccine is a split vaccine.

20. The method of claim 12 , wherein the first and/or the second influenza vaccine is a purified subunit vaccine.

21. The method of claim 12 , wherein the first and/or the second influenza vaccine includes influenza A virus neuraminidase.

22. The method of claim 12 , wherein the influenza vaccine comprising the second clade antigen is adjuvanted with an oil-in-water emulsion adjuvant.

23. The method of claim 1 , wherein the immunogenic composition comprises <15μg hemagglutinin antigen from the second clade of H5 influenza A virus.

24. The method of claim 12 , wherein the influenza vaccine comprises <15μg hemagglutinin antigen from the second clade of H5 influenza A virus.

Assignees

• Podda Audino
• Rappuoli Rino
• Seqirus Uk Ltd

Inventors

• Podda Audino
• Rappuoli Rino

Classifications

• A61P31/16

  for influenza or rhinoviruses · CPC title

• A61P37/00

  Drugs for immunological or allergic disorders · CPC title

• A61K2039/55566

  Emulsions, e.g. Freund's adjuvant, MF59 · CPC title

• A61K2039/53

  DNA (RNA) vaccination · CPC title

• A61K2039/5256

  expressing foreign proteins · CPC title